Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
020
|
Date of Entry 09/09/2008
|
FR Recognition Number
|
13-22
|
Standard | |
CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
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Scope/AbstractThis specification identifies the way bar coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar code labels on specimen tubes that are used on clinical laboratory analyzers. It enables Laboratory Information System vendors to produce reliable bar coded symbols that are readable by any complying clinical laboratory analyzer vendor. |
|
Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
|
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
|
Standards Development Organization
|
FDA Specialty Task Groups (STG)
Software/Informatics (primary) |
InVitro Diagnostics |
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*These are provided as examples and others may be applicable. |